title: Phase I study of oral S-1 plus Cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with cisplatin and thoracic radiotherapy in patients with unresectable Stage III non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  S-1 was administered orally twice daily for 14 days and cisplatin on Days 1 and 8 of each cycle; this was repeated every 3 weeks. Doses of each drug were planned as follows: level 0, 50/40; level 1, 60/40; level 2, 70/40; level 3, 80/40 (S-1 [mg/m(-2)/day(-1)]/cisplatin [mg/m(-2)/day(-1)]). Thoracic radiation therapy was administered in 2 Gy fractions five times weekly to a total dose of 60 Gy.
  
  
  RESULTS
  Ten patients were enrolled in this study. All patients received 60 Gy of thoracic radiotherapy and 7 (70%) patients received four cycles of chemotherapy. At level 1, 2 of 3 patients experienced a delay exceeding 10 days in the cisplatin administration of Day 29. Grade 4 neutropenia and Grade 3 fever occurred in 1 and 1 patients, respectively. Nonhematologic toxicities were mild. None developed >or=Grade 3 esophagitis or lung toxicity. At level 0, 2 of 7 patients developed dose-limiting toxicity. Thus, level 1 was considered the MTD and Level 0 was selected as the RD. Objective responses were seen in all patients.
  
  
  CONCLUSIONS
  The RD is the level 0 dose, and this regimen is a feasible and well-tolerated regimen for the treatment of patients with Stage III NSCLC.
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan. kkaira1970@yahoo.co.jp
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Kaira
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sunaga
authors.forename: Noriko
authors.initials: N
authors.lastname: Yanagitani
authors.forename: Tadayoshi
authors.initials: T
authors.lastname: Kawata
authors.forename: Mitsuyoshi
authors.initials: M
authors.lastname: Utsugi
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Shimizu
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ebara
authors.forename: Hidemasa
authors.initials: H
authors.lastname: Kawamura
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Nonaka
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ishikawa
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Sakurai
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Suga
authors.forename: Kenichiro
authors.initials: K
authors.lastname: Hara
authors.forename: Takeshi
authors.initials: T
authors.lastname: Hisada
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Ishizuka
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakano
authors.forename: Masatomo
authors.initials: M
authors.lastname: Mori
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin